Technology
The simple, safe & efficient point of care preparation of autologous platelet rich plasma
Device Technology
All Regen™ tubes consist of pharmaceutical-grade class I borosilicate and use vacuum for automated blood collection. The hallmark of the Regen™ technology is a thixotropic separating gel composed of a mixture of polymers for gravimetric plasma separation (elimination of RBC and WBC). RegenTHT, Regen BCT and A-CP are devices designed for the preparation of PRP and contain a sodium citrate anticoagulant solution above the separating gel. The RegenATS device does not contain anticoagulant. In this device, the plasma coagulates and a serum rich in activated thrombin is extracted from the plasma clot.
Regen Lab devices intended for PRP preparation consist of evacuated glass tubes containing a thixotropic gel with a specific density designed for platelet or platelet and MNC isolation, and anticoagulant solution. The gel acts as a mechanical separator of blood components, and sodium citrate solution as blood anticoagulant. Thixotropy is a physical property of some gels which are thick under static condition, become more fluid when submitted to physical stress (in this case, the centrifugal force) and regain their original consistency when the physical stress stops.
How it works
Thanks to the vacuum system, blood is gently collected into the tube and mixed with an anticoagulant by gentle inversion. The blood-filled device is centrifuged at 1500 g for 5 (A-CP and Regen BCT) or 9 minutes (RegenTHT). During centrifugation, the thixotropic separator gel becomes fluid and migrates upwards, while red and white blood cells move downwards. The gel forms a solid barrier, isolating platelets and plasma above it, while trapping RBC and most WBC below.
After centrifugation, platelets form a thin layer on the gel’s surface. To resuspend the platelets in the plasma, the tube is gently inverted repeatedly. The PRP is then collected using a blood transfer device and syringe, ready for physician use. This automated process ensures reliable and reproducible PRP isolation with high platelet recovery and low contamination levels, independent of the operator.
Preparation Process
- Collection: Blood is drawn into evacuated pharmaceutical grade borosilicate tubes containing an anticoagulant solution and separating polymer gel.
- Mixing: The blood is gently mixed with the anticoagulant by
gentle inversion of the tube. - Centrifugation: The tube is centrifuged for 5 to 9 minutes, depending on the model and gel type, using either a tabletop centrifuge with a fixed angle rotor or a larger centrifuge with a swing-out horizontal rotor.
Regulatory
Quality Management
Advantages of Regen Lab Technology
Regen Lab Technology is known for its advancements in regenerative medicine and biotechnology.
Minimally Invasive:
Treatments using Regen Lab Technology are typically minimally invasive, reducing the need for extensive surgery and allowing for quicker recovery times.
Enhanced Healing and Recovery:
PRP and similar therapies can accelerate the healing process for various conditions, including sports injuries, osteoarthritis, and chronic wounds, by enhancing the body’s natural healing mechanisms.
Reduced Risk of Rejection:
Since the treatments often use the patient’s own cells and blood components, there is a lower risk of rejection or adverse reactions, ensuring a safer therapeutic approach.
Versatility:
Regen Lab Technology can be applied across a wide range of medical fields, including orthopedics, dermatology, aesthetics, and dental medicine, making it a versatile tool in modern healthcare.
Customization:
The technology allows for personalized treatment plans tailored to the specific needs of each patient, leading to more effective outcomes.
Cost-Effective:
Compared to some traditional treatments and surgeries, regenerative therapies can be more cost-effective in the long run due to quicker recovery times and reduced need for additional interventions.
Regulatory Approval:
Many of Regen Lab’s products have received regulatory approval from agencies such as the FDA and CE, ensuring compliance with high standards of safety and efficacy.
Patient Satisfaction:
High levels of patient satisfaction are reported due to the natural and lasting results of regenerative treatments, contributing to an overall improved quality of life.
The RegenLab® USA technology is based on the use of a thixotropic gel to separate blood components. Thixotropy is a physical property of some gels. The gel acts as a mechanical separator of the blood components. To learn more about the patents protecting this process, please visit www.regenlabusa.com/patents.
Thixotropy is a physical property of some gels. The gel is thick under static conditions. It becomes more fluid when submitted to physical stress (in this case, a centrifugal force of 1500 g) and regains its original consistency when the physical stress stops (Barnes, 1997).
The gel acts as a mechanical separator of the blood components. Two types of thixotropic gels with different specific densities are used in Regen Lab devices. One type is designed to separate platelets only, while the other allows the recovery of platelets with mononuclear cells (lymphocytes and monocytes). Performance studies have shown that the Regen tubes are reliable and produce a consistent separation of platelets and plasma from erythrocytes and leukocytes.
Regen Lab medical devices consist of evacuated pharmaceutical grade borosilicate tubes that contain a pharmaceutical grade anticoagulant solution and a separating polymer gel specifically designed for PRP isolation. The vacuum in the tube allows the preparation of PRP in fully closed circuit. A predetermined amount of blood (8-10 mL) is automatically collected in the tube by connecting it to a blood collection set. Using an evacuated tube for blood collection is not only less traumatic for the blood than using a syringe but is also safer for the operator and the patient.
Blood is mixed with the pre-loaded anticoagulant by gentle inversion of the tube and centrifuged for 5 to 9 minutes depending on the model of tube and the type of separating gel. The centrifugation can be performed using either a small tabletop centrifuge equipped with a 45° fixed angle rotor or in a larger centrifuge with a swing out horizontal rotor.
Technology
All RegenLab® products use patented separating gel technology for the standardized production of cell therapy products with reproducible cell profiles.
The separating gel positions itself in a controlled manner within the buffy coat during centrifugation and forms a stable physical barrier that isolates the platelets and plasma in the upper part of the tube, while almost all of the unwanted erythrocytes and a large part of the neutrophil granulocytes are bound in the lower part . The resulting RegenPRP™ is a homogeneous plasma PRP with high platelet recovery (>70-80%), a low WBC concentration with almost quantitative depletion of pro-inflammatory neutrophils, and virtually no erythrocytes. The separating gel ensures that a PRP with a reproducible cell profile, the RegenPRP™, can be produced if the manufacturing protocol is followed. The closed system ensures sterile processing that is safe for patients and users.
Technology
All RegenLab® products use patented separating gel technology for the standardized production of cell therapy products with reproducible cell profiles.
The separating gel positions itself in a controlled manner within the buffy coat during centrifugation and forms a stable physical barrier that isolates the platelets and plasma in the upper part of the tube, while almost all of the unwanted erythrocytes and a large part of the neutrophil granulocytes are bound in the lower part . The resulting RegenPRP™ is a homogeneous plasma PRP with high platelet recovery (>70-80%), a low WBC concentration with almost quantitative depletion of pro-inflammatory neutrophils, and virtually no erythrocytes. The separating gel ensures that a PRP with a reproducible cell profile, the RegenPRP™, can be produced if the manufacturing protocol is followed. The closed system ensures sterile processing that is safe for patients and users.
Technology
All RegenLab® products use patented separating gel technology for the standardized production of cell therapy products with reproducible cell profiles.
The separating gel positions itself in a controlled manner within the buffy coat during centrifugation and forms a stable physical barrier that isolates the platelets and plasma in the upper part of the tube, while almost all of the unwanted erythrocytes and a large part of the neutrophil granulocytes are bound in the lower part . The resulting RegenPRP™ is a homogeneous plasma PRP with high platelet recovery (>70-80%), a low WBC concentration with almost quantitative depletion of pro-inflammatory neutrophils, and virtually no erythrocytes. The separating gel ensures that a PRP with a reproducible cell profile, the RegenPRP™, can be produced if the manufacturing protocol is followed. The closed system ensures sterile processing that is safe for patients and users.
STANDARDIZED AUTOLOGOUS PREPARATION
With the ability to rapidly generate fresh autologous preparations at point of care, cellular components are selectively isolated in a manner which not only serves to maximize their biocompatibility, but also their bioactivity. This allows Platelets, and their supporting elements, to maintain their function whilst being concentrated in a manner which ensures the utmost standard of purity, thanks to what we have termed as the “GMP Lab in a Tube.”
ACADEMIC COLLABORATION
RegenLab® works closely with leading experts around the globe in order to assess and refine approaches with the goal of revolutionizing approaches toward regenerative medicine and improving quality of life for the patient.
Our academic partnerships represent a key component of our mission, to further initiatives of both public health and patient welfare.
CLINICAL EXPLORATION
With Platelets already having a proven role in the healing of tissues (e.g. as key components in migration, proliferation and differentiation), the importance of further study in this regard is paramount in our initiatives.
With over 200 publications worldwide, and 4 textbooks published in collaboration with the BioBridge Foundation and our academic partners, RegenLab® prides itself as a leader of clinical advancement in the field of Regenerative Medicine.
PERSISTENT INNOVATION
With this methodology comes a persistent need to raise the bar, innovating new technological approaches to further develop the fields of Cell Therapy &; Tissue Engineering.
RegenKit® Medical Device Kits represent just the beginning, with a significant portfolio of RegenLab® technology under investigative status and pending FDA Clearance or Approval.